Details for New Drug Application (NDA): 020392
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NDA 020392 describes CYSTAGON, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTAGON profile page.
The generic ingredient in CYSTAGON is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
The generic ingredient in CYSTAGON is cysteamine bitartrate. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 020392
| Tradename: | CYSTAGON |
| Applicant: | Mylan |
| Ingredient: | cysteamine bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 020392
| Mechanism of Action | Cystine Disulfide Reduction |
Suppliers and Packaging for NDA: 020392
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYSTAGON | cysteamine bitartrate | CAPSULE;ORAL | 020392 | NDA | Mylan Pharmaceuticals Inc. | 0378-9040 | 0378-9040-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05) |
| CYSTAGON | cysteamine bitartrate | CAPSULE;ORAL | 020392 | NDA | Mylan Pharmaceuticals Inc. | 0378-9045 | 0378-9045-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Aug 15, 1994 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 150MG BASE | ||||
| Approval Date: | Aug 15, 1994 | TE: | RLD: | Yes | |||||
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